Facilitating enterprise wide EU-MDR compliance to continue sale of products in the EU

Wipro performed a gap assessment to the new EU MDR and remediated the gaps, thus ensuring compliance aligned to the customer’s aggressive acquisition strategy.

Client Background

Client: The client is the world’s largest medical technology and solutions provider with 8 business lines to address different health needs
Industry Type: Medical devices
Products and Services: Medical technology, services and solutions
Geography: Global

Challenges

The new EU MDR Regulation 2017, with newer and stricter regulations / rules, makes it challenging to register legacy products in the EU. The scope of this project was to perform a gap assessment on the new EU MDR and then remediate the gaps. Wipro was chosen to perform a gap assessment and remediation of more than 1,000 products from a large legacy product portfolio. These gaps were in several areas such as design, quality, risk management, labeling, clinical evaluation, and post market surveillance. Remediation activities included creation of design history files, position papers, justification memos, specification development, test method development, verification plans / protocols, testing, and validation.

The key challenges were:

The EU Medical Device Directive will become a regulation by May 26, 2021.
The customer had a large portfolio of products, which needed to comply with the new regulation within a short span of time. Some products classification would change to the higher risk classification due to the regulation.
Some products needed to change material as they were deemed as carcinogenic, mutagenic and harmful for human reproduction. These products would have to undergo design validation testing.

Solution

Key aspects of the solution included:

Interpret the regulation and come up with a strategy to provide evidence for technical documentation
Evolve a checklist for technical documentation and use it to perform gap assessments
Provide rationale for gaps and work with SMEs to close gaps
Update or develop specifications, DHF and document attributes in document management system using change management process
Wherever specifications are updated or newly developed - assess test methods, develop and validate if tests are unavailable
Update hazardous substances list into product governance and compliance database
Work with SMEs to initiate record change orders and data change orders

Business Impact

The customer benefitted with reduction of more than 18,000 hours of effort put in by temporary team members and cost savings associated with these efforts which were predominantly onsite
Fast ramp up with offshore support to achieve better time to market
The customer’s principal engineers focused on day-to-day priorities. Wipro helped them free up their time for strategic initiatives
70 technical files representing more than 1,000 unique products were remediated in a very short time
Saved more than $ 2M by outsourcing the project to Wipro

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Facilitating enterprise wide EU-MDR compliance to continue sale of products in the EU

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